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Food Safety Modernization Act › Food Safety › Regulatory Oversight

The Food Safety Modernization Act is a United States federal statute enacted in 2011 to ensure the safety of the U.S. food supply and prevent food contamination. The main features of the FSMA include expanding... more +
The Food Safety Modernization Act is a United States federal statute enacted in 2011 to ensure the safety of the U.S. food supply and prevent food contamination. The main features of the FSMA include expanding the FDA's inspection of food processing facilities and imported food products, requiring all food processors, manufactures and handlers to register with HHS and maintain food safety records, and shifting the government's focus away from responding to food contamination and towards preventing food contamination.  less -
Hogan Lovells

OMB releases Fall 2022 Unified Agenda of Regulatory Actions

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The Office of Management and Budget (OMB) recently released the Fall 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

Hogan Lovells

FDA Extends Enforcement Discretion for Several Requirements in FSMA Regulations

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FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...more

Hogan Lovells

FDA Holds Summit on E-Commerce and Food Safety

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The U.S. Food and Drug Administration (FDA) recently hosted a three-day virtual summit on e-commerce, which focused on food safety for foods ordered online and delivered directly to consumers. Because of the increasing...more

Morgan Lewis - Well Done

FDA Signs Domestic Mutual Reliance Agreements with Four States to Protect Food Supply

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FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution systems. FDA’s goal is to...more

Hogan Lovells

FDA reviews New Era of Smarter Food Safety accomplishments

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The U.S. Food and Drug Administration (FDA) recently issued a review of work done over the last year in advancing its New Era of Smarter Food Safety (New Era) Blueprint, which was released in July 2020. In a corresponding FDA...more

Hogan Lovells

FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future Operations

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The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities across all parts of the agency during...more

Hogan Lovells

FSMA update: FDA announces pilot program to evaluate third-party food safety standards

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The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more

Wiley Rein LLP

Farm-to-Table Traceability Is on Its Way: FDA Issues Proposed Rule

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On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to establish additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold certain high-risk...more

Hogan Lovells

FDA Announces Inspections of Small Businesses under FSMA Intentional Adulteration Rule to Begin March 2021

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The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will...more

Hogan Lovells

FDA Releases Blueprint for the New Era of Smarter Food Safety

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The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s...more

Hogan Lovells

OMB Releases Spring 2020 Unified Agenda of Regulatory Actions

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The Office of Management and Budget (OMB) recently released the Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2020 #3

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LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more

Hogan Lovells

FDA Releases Third and Final Installment of Draft Guidance for FSMA Intentional Adulteration Rule

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The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more

Hogan Lovells

OMB Releases Fall 2019 Unified Agenda of Regulatory Actions

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The Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

Hogan Lovells

FSMA Update: FDA Announces Continuation of Enforcement Discretion for Co-Manufacturer Supplier Verification

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On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to...more

Hogan Lovells

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

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The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more

Hogan Lovells

FDA Holds Public Meeting on “A New Era of Smarter Food Safety” to Further FSMA Implementation

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On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l October 2019 #2

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LEGISLATION, REGULATIONS & STANDARDS - FDA Warns Company Selling CBD Oil - The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a...more

Hogan Lovells

FSMA Update: FDA Launches “FDA-TRACK: Food Safety Dashboard” to Track FSMA Progress

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The U.S. Food and Drug Administration (FDA) has launched two new online dashboards that track key metrics reflecting the impacts from the FDA Food Safety Modernization Act (FSMA) regulations. The dashboards are part of...more

Hogan Lovells

FSMA Update: FDA Publishes List of Required Foreign Supplier Verification Program Records

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The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation....more

Hogan Lovells

FDA Announces Public Meeting and Docket for Comments on “A New Era of Smarter Food Safety” to Facilitate FSMA Implementation

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The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding “A New Era of Smarter Food Safety.” As explained in more detail in this memorandum, as part of...more

Hogan Lovells

Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions

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Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the...more

Perkins Coie

Industry Insights: FDA Sends First Warning Letter Under Recent Rule Regarding Imported Food

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The Food Safety Modernization Act (“FSMA”) ushered in a sea change in the government’s regulation of food safety. Pursuant to FSMA, the FDA has promulgated a series of rules, including a 2015 rule related to the Foreign...more

Hogan Lovells

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

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The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

Hogan Lovells

FDA Issues Draft Guidance on Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting

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FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting,...more

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